Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Pharmacokinetics of Tamsulosin in Healthy Male Volunteers

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02264184
• Collaborator: (none)
• Enrollment: 24
• Arms: 2

Study Details

Study Description

Brief Summary

Study to investigate the effect of CYP2D6 inhibition by paroxetine on the single oral dose pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Tamsulosin; Drug: Paroxetine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Randomized Two-way Crossover Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Single Oral Dose Pharmacokinetics of Tamsulosin in Healthy Male Volunteers (CYP2D6 Extensive Metabolizers)
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tamsulosin + Paroxetine Tamsulosin: q.d on day 1 Paroxetine: higher dose q.d. on days -7 to 2 q.d., lower dose on days -10 to -8 and 3 to 5	Drug: Tamsulosin; Other Names: Alna® ; Drug: Paroxetine; Other Names: Tagonis®
Active Comparator: Tamsulosin Tamsulosin: q.d on day 1	Drug: Tamsulosin; Other Names: Alna®

Outcome Measures

Primary Outcome Measures

1. Cmax (maximum measured concentration of tamsulosin HCl in plasma) [up to 48 hours after dosing]

2. AUC0-∞ (area under the concentration-time curve of tamsulosin HCl in plasma over the time interval from 0 extrapolated to infinity) [up to 48 hours after dosing]

Secondary Outcome Measures

1. tmax (time from dosing to the maximum measured concentration of tamsulosin HCl in plasma) [up to 48 hours after dosing]

2. AUC0-tz (area under the concentration-time curve of tamsulosin HCl in plasma over the time interval from 0 to the last quantifiable data point) [up to 48 hours after dosing]

3. λz (terminal rate constant of tamsulosin HCl in plasma) [up to 48 hours after dosing]

4. t1/2 (terminal half-life of tamsulosin HCl in plasma) [up to 48 hours after dosing]

5. MRTpo (mean residence time of tamsulosin HCl in the body after oral administration) [up to 48 hours after dosing]

6. CL/F (apparent clearance of tamsulosin HCl in plasma after an extravascular administration) [up to 48 hours after dosing]

7. Vz/F (apparent volume of distribution of tamsulosin HCl during the terminal phase λz following an extravascular administration) [up to 48 hours after dosing]

8. RCmax,T/R (ratio of the Cmax value of the test treatment to the Cmax value of the reference treatment after single dose) [up to 48 hours after dosing]

9. RAUC0-∞,T/R (ratio of the test treatment versus the reference treatment from zero to infinity, expressed as ratio of AUC values after single dose) [up to 48 hours after dosing]

10. Number of subjects with adverse events [up to 21 days after last treatment]

11. Assessment of tolerability by investigator on a 4-point scale [within 21 days after last treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

All participants in the study are

• Healthy males

• Ranging from 21 to 50 years of age

• Body mass index (BMI) within 18.5 to 29.9 kg/m2

• In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances

• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

• History of orthostatic hypotension, fainting spells or blackouts

• Chronic or clinically relevant acute infections

• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator

• Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study

• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study

• Participation in another trial with an investigational drug (within two months prior to administration or during the trial)

• Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)

• Inability to refrain from smoking on trial days

• Alcohol abuse (> 60 g/day)

• Drug abuse

• Blood donation (> 100 mL within four weeks prior to administration or during the trial)

• Any laboratory value outside the reference range if indicative of underlying disease or poor health

• Excessive physical activities within the last week before the trial or during the trial

• Hypersensitivity to treatment medication and/or related drugs of these classes

• Non extensive metabolizer (EM) for CYP2D6

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02264184
• Other Study ID Numbers: 527.79
• First Posted: Oct 15, 2014
• Last Update Posted: Oct 15, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Paroxetine; Tamsulosin

Study Results

No Results Posted as of Oct 15, 2014